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Tricol’s Hemostatic Devices Have What It Takes, According to ECRI

ECRI, a well-known and trusted voice in healthcare, focused on quality, safety and cost, across the healthcare spectrum, analyzed hemostasis pads. They identified four key considerations to help choose the best. Tricol Biomedical offers two hemostatic devices for vascular closure; the HemCon® Patch Pro, and the HemCon® OneStopTM Vascular. Tricol Biomedical’s Chief Science Officer, Dr. Simon McCarthy, describes how the HemCon® OneStopTM Vascular Patch meets and even exceeds ECRI’s stringent considerations.

ECRI’s Key Considerations

  • Will the hemostatic agent be effective on a patient whose coagulation is compromised due to systemic anti-coagulation treatment?
  • Does the hemostasis device have a backing?
  • Can the width and length of the hemostasis pad meet the needs of the wound?
  • Can the pad be used for vascular access sites, percutaneous catheters, lacerations, and trauma?

The Tricol Standard Isn’t Typical

While many companies participate in the billion-dollar vascular closure market, Tricol Biomedical’s HemCon® product line stands apart. HemCon’s unique chitosan technology was leveraged by the U.S. Army in 2001 with the mission to control severe, traumatic bleeding on the battlefield. Soon thereafter, all US soldiers carried the original HemCon® Bandage in their individual first aid kits. This was advanced breakthrough technology, saving many lives. This same battlefield technology is also offered in acute care settings with HemCon’s OneStopTM Vascular and Patch Pro Devices.

It’s All in a Pad

The HemCon® OneStopTM Vascular meets the stringent requirements as outlined by ECRI, and more…

  • It is cleared for use to control bleeding in all patients, including those on anticoagulation therapy. Criteria #1 met.
  • OneStopTM Vascular has a backing with clear instructions indicating the active side of the patch as well as instructions not to remove. Criteria #2 met.
  • OneStopTM Vascular is 1.5in x 1.5in and is used in a wide range of wound sizes. Criteria #3 met.
  • OneStopTM is indicated for vascular procedure sites and sites involving percutaneous catheters, tubes and pins, and can be used to control bleeding from lacerations and/or trauma. Criteria #4 met.

Meeting ECRI’s criteria outlined above is great, but the HemCon® OneStopTM Vascular Patch provides 2 additional important features that go beyond the criteria set forth by ECRI.

  • Promotes Rapid Control of Bleeding
  • Provides a Barrier to Bacterial Penetration of the Dressing

Tricol also offers a radial balloon compression device with the OneStopTM Vascular patch incorporated into the design of the device. This device is called the OneStopTM ChitoPulse. This product offers the same features and benefits listed above.

Solid Science for Peace of Mind

Tricol’s secret is in the science. (Well, it’s also in “trade secrets,” but we can only share the science.) Unlike other players in the hemostasis field, Tricol’s products have earned support from a plethora of impressive studies on their efficacy.

A combination of well-funded preclinical and clinical data continuously reinforces the remarkable performance of these hemostatic devices. Supported by solid, proven data, clinicians confidently use them for lacerations, trauma wounds, vascular-procedure sites, and sites involving percutaneous catheters. Bleeding is controlled quickly and safely by the power of products strengthened by science and perfected by experts.

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HemCon Chitosan Hemostatic Devices and the Body’s Clotting Cascade

In our final article of our first of many educational series, we are going to review the body’s natural clotting cascade and how HemCon’s hemostatic devices do not rely on this process to control bleeding.  We often talk about how our products work “outside of the clotting cascade” but what does that really mean? What is the clotting cascade and why does it matter that HemCon products work outside of it?  First, we must understand the clotting cascade. By quickly glancing at the diagram on this page, it will make perfect sense…. Well, perhaps an explanation is necessary. The human body is full of complex processes that are truly amazing, and the clotting cascade is certainly one of them.

Don’t worry about the above diagram. What you need to know is that when you cut yourself and you want the bleeding to stop, or when a physician performs surgery and needs to stop the bleeding post-procedure, there are many things within your bloodstream that need to happen for it to successfully form a clot. In fact, there are 13 “clotting factors,” and each factor has an “inactive” form that gets converted into an “active” form to enable clotting. This conversion is the clotting cascade.

Before we go further, let’s get some common definitions out of the way:

  1. Clotting Factors – any of several substances in blood plasma that are involved in the clotting process, such as calcium, prothrombin, Fibrogen, and tissue. Each clotting factor is assigned a number 1 through 13.
  2. Collagen – the main structural protein found in the skin and other connective tissues.
  3. Prothrombin – a protein in blood plasma that gets converted into thrombin.
  4. Thrombin – an enzyme in blood plasma which causes the clotting of blood by converting fibrinogen into fibrin.
  5. Fibrinogen – a soluble protein in blood plasma from which fibrin is produced thanks to the action of thrombin.
  6. Fibrin – an insoluble protein formed from fibrinogen during the clotting of blood. It forms a “fibrous” mesh that impedes the flow of blood… the clot!
  7. Platelets – small cells in the blood that help with forming blood clots.

When there is damage to a blood vessel (from an unanticipated cut, or surgical procedure), collagen is exposed to circulating platelets in the blood. These platelets bind directly to collagen and create a platelet plug. This is the first thing that happens, triggering the clotting cascade. We mentioned above that there are 13 factors that need to convert from inactive to active inside the clotting cascade.  These 13 factors are organized in what is referred to as pathways, the intrinsic pathway and the extrinsic pathway. The intrinsic pathway is activated when there is direct damage to the blood vessel.  The extrinsic pathway is activated by direct damage to the blood vessel as well, but also by many other things such as tissue damage outside of the blood vessel, hypoxia, sepsis, malignancy, and inflammation. Think of these paths as separate roads, each with different factors with conversion processes that ultimately come together at factor 10 to form one road, starting the common pathway.  And within the common pathway, the 2 most important factors are thrombin and fibrin.

Fibrin is factor number 1, the protein that forms a mesh, trapping platelets and ultimately creating the clot. But it cannot happen without thrombin, factor number 2, which plays a big role in activating many of the other factors, both within the intrinsic and extrinsic pathways (factors 5,7,8,11 and ultimately 13). Factor 13 is the last and final clotting factor number.  When you’ve reached factor 13, your blood has formed a clot!

By now you are an expert at understanding the body’s natural clotting cascade. Maybe not, it can be confusing even for those that are somewhat familiar with it. It is truly amazing that this process takes place every day in all of us when we cut ourselves or have a planned event. And now that you know about it, we can get back to the original question of how the HemCon hemostatic devices work “outside of the clotting cascade,” and why it matters.

If you cut yourself and use a store-bought bandage or piece of gauze, and apply gentle pressure to stop the bleeding, you will need the clotting cascade to kick into gear and allow the process to run its course, ultimately creating a clot (thrombin to fibrinogen to fibrin). Think about all the factors mentioned above! This process works fast in some people, and very slow in others. For patient’s on blood thinners (anti-coagulants) their pace of clotting is slowed by impacting certain factors limiting thrombin’s ability to exercise its power in creating a clot. There are also certain diseases like hemophilia or Von Willebrand disease that hinder the ability of the clotting cascade in affected individuals. The clotting cascade does not always cooperate as it does on paper and charts.  Getting the clotting cascade to work could take a very long time in some cases.

This is where “working outside the clotting cascade” comes into play for the HemCon hemostatic devices. Our positively charged chitosan devices simply attract the negatively charged platelets and blood cells to create a strong clot at the wound site, meaning, you do not have to worry about all those factors in the clotting cascade running their course. Of course, they will run their course behind the scenes, but HemCon devices do not rely on them at all. Other hemostatic devices made from other sources work by affecting the extrinsic pathway, speeding up the clotting cascade process, but still must rely on part of the clotting cascade being intact.

The HemCon hemostatic devices have been stopping bleeding since 2001 when first introduced by the U.S. Army to control traumatic bleeding. Being able to “work outside of the clotting cascade” played a large role in their decision to supply HemCon products to U.S. Soldiers.

 

 

 

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Chitosan’s Anti-Bacterial Properties

It has been over one year since the world was shut down in response to COVID-19. Since then, the general population has become more in tune with proper health and safety practices such as washing hands and wearing masks. Wearing a mask has become an important practice used to prevent respiratory droplets from reaching others. Face masks have found their place as a simple barrier to aid in the prevention of illness. Shouldn’t it be just as important that your injuries, whether through planned hospital procedures or unexpected events, are provided that same protection?  Many of HemCon’s bleeding control products provide an antibacterial barrier against 24 microorganisms.

As you learned in article 2 of this series Chitosan Performance in the Human Body, the HemCon bandage type dressings provide a technology that adheres tightly to blood and seals the injury site to stop bleeding. Equally important is that this adhesion process also provides an antibacterial barrier, blocking the ability of bacteria to penetrate the wound.

 

 

Proper application and removal of HemCon products play an important role here. When HemCon Chitosan dressings come in contact with blood, they essentially create an instant clot, adhering to the wound, creating a very tight seal that can’t be penetrated. The dressing can be left in place on the patient for up to 48 hours providing continuous protection! However, improper technique could jeopardize this important safety feature. Lifting up the dressing and peeking underneath to see if bleeding is controlled can break the strong seal and could compromise the dressing’s ability to provide the bacterial barrier. (Note: Not all HemCon dressings provide this barrier to bacteria. Check the product descriptions on our website for products that carry this claim.)

The antibacterial barrier of HemCon dressings was investigated using a standardized test method, Evaluation of Antibacterial Finishes, where the dressing was exposed to single strains of Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. HemCon bandages exhibited a >99% reduction in organisms 24 hours after being exposed to the dressing. The most common microorganisms causing surgical site infection are Staphylococcus aureus and enterococcus faecalis. (Read the full article here.)

The unique properties of chitosan, the correct delivery matrix for the wound type, and good clinical practice produce a powerful barrier against some of the most prevalent bacteria found in hospitals.